MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 5F X 5CM; INTRODUCER, CATHETER

Model Number N/A

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redv3651 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when placing the catheter on (b)(6) 2020, the operator opened the package and found that the guide wire was kinked.

Event Description

It was reported that when placing the catheter on (b)(6) 2020, the operator opened the package and found that the guide wire was kinked.

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and batch history, labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kinked guidewire was confirmed but the cause is unknown.No residual material was seen on the returned sample.The distal end of the guidewire was not found protruding from the tip straightener but was instead caught within the packaging loop/tip straightener.The proximal end of the guidewire was seen protruding from the packaging loop.Kinks were noted 0.3¿, 0.6¿, 0.7¿, 0.8¿ and 1.4¿ from the distal end of the guidewire.Microscopic examination revealed that the coils on the wire were misaligned where the wire had been kinked but the coil wire was unbroken.Examination of the distal end of the wire confirmed that the weld tip was intact.An attempt was made to pass the guidewire, through the tip straightener.The guidewire would bend in the kinked locations and therefore could not be easily passed through the tip straightener.The guidewire was then fed through the tip straightener, starting with the stiff proximal end.The guidewire could be fed through the tip straightener, indicating that there is not a stack-up issue between the guidewire and the tip straightener.A small amount of resistance was felt when feeding the kinked section through the tip straightener as the kinks rubbed along the inner walls of the tip straightener.Based on evaluation of the sample, possible contributing factors include manufacturing related causes (e.G.Damaged component used or forcing the guidewire into the packaging sheath) of use related causes (e.G.Forcing the guidewire against resistance in the tip straightener or introducer needle).However, the exact root cause cannot be determined at this time.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 5F X 5CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10678744
• MDR Text Key: 213414149
• Report Number: 3006260740-2020-20105
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 0668950
• Device Lot Number: REDV3651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other